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How to Use Volume 2

1.   WHAT IS VOLUME 2?

Volume 2 gives information to applicants to enable them to determine the category under which an application must be made.

On 1 July 2005, amendments to Schedules 6 and 7 of the Agvet Code Regulations revised the fees and structure of the application categories which had existed since 1993. The existing 50 application categories were revised into 25 categories.

Appendix A shows a comparison between the pre-July 2005 application categories and the current application categories.

The aim of Volume 2 is to enable applicants for approval of a new active constituent, or registration of a new agricultural or veterinary (agvet) chemical product, or approval of a label, or variations to a product, active constituent or label, to easily determine:

• the correct application category
• the fee and timeframe applicable to the application
• data requirements for the application.

2.   HOW DOES AN APPLICANT USE VOLUME 2?

An applicant may apply to the APVMA for:

• approval of a new active constituent
• registration of an agricultural or veterinary product
• approval of an agricultural or veterinary product label
• variation of the particulars or conditions of product registration
• variation of the particulars or conditions of label approval
• variation of the particulars or conditions of approval of an approved active constituent
• issue of a permit
• any other assessment of a technical nature.

Applications must be made under one of the 25 application categories depending on the purpose of the application and the nature of the active constituent or product.

The application categories are derived from Schedule 6 to the Agvet Code Regulations (see Appendix B) and the categories correspond with the item numbers in column 1 of Schedule 6.

Schedule 6 also provides the application fee and timeframe for fixed categories.

Of the 25 application categories, 18 have a fixed application fee and assessment period and seven (categories 2, 10, 14, 21, 23 and 25) have a modular application fee and assessment period. The modular application categories are further explained the relevant application category chapters in this volume, and in ‘Module levels for modular categories’ in Volume 3.

A summary of the application categories is shown in Table 1.

Table 1: Summary of application categories

Category	Type of application
1	Application for approval of a new active constituent and registration of a product and approval of the label (agricultural products only)
2	Application for approval of a new active constituent and registration of a product and approval of the label: modular
3–10	Application for registration of a product containing an approved active constituent and approval of the label (Categories 3 & 4 apply only to agricultural products)
11–14	Application to vary a product or label (Category 11 applies only to agricultural products)
15–17	Application for approval of an active constituent
18	Application for variation to approval of an active constituent
19–23	Application for a permit
24–25	Other applications

Data requirements for each application category are set out in the relevant category chapter in this volume and in ‘Module levels for modular categories’ in Volume 3.

The APVMA evaluates applications against criteria of safety and efficacy. These criteria are explained in ‘Legal background to the National Registration Scheme’ in Volume 1.

2.1.   Step-by-step use of Volume 2

1. Determine the application category
• use the category decision tree at paragraph 4.
2. Determine data requirements, fee and timeframe
   • go to the specific application category chapter in Volume 2. This will provide general information on data requirements and will provide the fee and timeframe.
3. Get further details on data requirements in Volume 3
   • go to Volume 3 for further details on data requirements:
     • if the application category is a modular category, ‘Module levels for modular categories’ will provide a list of data studies required for each type of application
     • if the application category is a fixed category, ‘Module levels for modular categories’ will also provide a list of data studies required for each type of application, because data requirements for fixed application categories are also linked to data modules.
   • Volume 3 also has specific guidance on each of the 10 data parts, which are:

   Part 1	Application Overview
   Part 2	Chemistry and Manufacture
   Part 3	Toxicology
   Part 4	Metabolism and Kinetics
   Part 5	Residues and Trade
   Part 6	Occupational Health and Safety
   Part 7	Environment
   Part 8	Efficacy and Host Animal Safety
   Part 9	Other Trade Aspects
   Part 10	Special Data Requirements

3.   HOW IS THE APPLICATION CATEGORY DETERMINED?

The category decision tree commencing at paragraph 4 show how the application category is determined.

The first step is to decide on the broad purpose of the application. From this, a range of possible categories can be determined.

Note that the category decision tree is relevant to the great majority of applications, but may not be relevant to a minority of specialised applications. For these specialised applications, further information and guidance is provided in specific category papers of this volume.

An applicant must nominate the relevant category on the application form, as described in ‘Procedures for making an application’ in Volume 1.

3.1.   Modular application categories

Seven of the application categories (2, 10, 14, 21, 23, 24, 25) are modular categories. This means that data requirements for an application will be made up of a number of modules, of the data parts for chemistry, toxicology, residues and trade, occupational health and safety, environmental safety, efficacy and crop/animal safety, and finalisation of the application.

After working through the category decision tree an applicant may realise that the application fits one of the modular categories. If so, the applicant should refer to ‘Module levels for modular categories’ in Volume 3, to find further information on the data requirements for each module.

4.   CATEGORY DECISION TREE

Beginning with Diagram 1, applicants should work through the category decision tree until they reach the category that suits their application, referring to the instructions on the previous pages if necessary.

Diagram 1. First step of category decision tree

Diagram 2. Registration of a new product (Categories 1–10)

Diagram 3. Variation of a registered product or label (Categories 11–14)

 

Diagram 4. Approval of an active constituent or variation to an approved active constituent (Categories 15–18)

Diagram 5. Permit (Categories 19–23) Other applications (Categories 24–25)

5.   REQUIREMENTS AND GUIDELINES

Requirements may vary for a particular application category. Applicants should carefully read the relevant category chapter to discover the specific requirements and guidelines for that category.

Each application category also has specific data requirements. To determine the exact data requirements, refer to the specific category chapter and also Volume 3: Data requirements and guidelines.

5.1.   Application and data

Applicants must provide with their application:

1. One copy of the combined Application Form and Overview

The details which must be provided in the combined Application Form and Overview are slightly different for each application category. Applicants should refer to the specific category chapter in this volume for further information.

More information on the combined Application Form and Overview can be found in ‘Part 1 – Application Overview’ in Volume 3.

2. One copy of each of the relevant data Parts

Data requirements for each application category are provided in the specific category chapters in this volume and in Volume 3: Data requirements and guidelines.

5.2.   Labels

Applicants must provide a label with the Application Form and Overview. The APVMA recommends that the label be in draft form so that it can be amended if necessary, however applicants may choose to submit the marketed product label (MPL).

Applicants may provide the draft label as either:

• two copies of the text label (TXL) printed on paper; or
• an e-label on CD. The CD must be attached to the Application Form and Overview and not submitted separately or by email.

The draft label must include all label components ie primary pack, immediate container and leaflet, as relevant.

All parts of the draft label must be in accordance with the latest editions of the:

• Labelling Code; and
• Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP); and
• Handbook of First Aid Instructions and Safety Directions (FAISD Handbook).

After the APVMA has assessed the draft label and is satisfied that the label is acceptable, the APVMA will ask the applicant to provide an e-label of the MPL for approval. If the MPL is acceptable and all other matters relevant to the application are acceptable, the APVMA will approve the label and grant the application.

Refer to Label Approval Process in Volume 5 for further information.

5.3.   Fees and assessment timeframes

The fee and assessment timeframe for each category are shown in Appendix B.

5.4.   Screening the application

Details of the screening process are in ‘Procedures for making an application’ in Volume 1.

Once the application passes screening the APVMA will usually request additional copies of data for distribution to relevant agencies or reviewers for technical evaluation.

6.   DATA PROTECTION

The APVMA is limited from using protected data from one application for the purpose of granting another application without the consent of the appropriate authorising party. See the APVMA website data protection for further details on data protection. A summary of data protection is provided in Volume 1: ‘Legal Background to the National Registration Scheme’.

If applicants cannot provide consent for use of protected data, applicants must provide their own data to meet the relevant APVMA requirements.

When proposing an application category, applicants must be aware that with respect to data protection, the APVMA will only evaluate an application under an application category which has data requirements appropriate for the assessments required. This is shown in the following flowchart:

Appendix A: Comparison of pre-1 July 2005 application categories and current application categories

Pre-1 July 2005 Application Category	Fee	Timeframe (months)	Current Application Category	Fee	Timeframe (months)
NEW PRODUCTS
1	$20,620	15	1	$53,745			15
2	$2,060	15	2	Modular
3	$6,185	15
4	$1,030	15
5	Modular
6	$620	as primary
7	$4,125	8
8	$4,125	8
9	$2,060	5
10	$1,030	5
11	$620	5
12	$12,370	8	10	Modular
13	$1,030	8
Vet 14	$12,370	8
Ag 14	$12,370	8	4	$23,330			15
Ag 15	$12,370	13	3	$34,925			15
Vet 15	$12,370	13	10	Modular
16	$1,030	8
17	$620	8
18	Modular
19	$620	5
20	$3,095	8
21	$1,650	5
22	$6,185	8
23	$1,030	8
23A	$310	3	8	$595		3
			or 10	Modular
24	$3,095	5	5	$3,630			5
25	$3,095	Modular	10	Modular
26	$1,030	3	6	$2,470			5
			or 7	$660			3
27	$620	3	8	$595			3
28	$12,370	8	10	Modular
29	$5,155	8
30	$1,030	3
			9 (listed reg)	$545			3
NEW ACTIVE CONSTITUENT
31	$6,000	12	15	$25,775			12
			or 16	$4,430			8
			or 17	$1,580			5
VARIATION TO PRODUCT/LABEL
32	$10,310	8	11	$15,685			8
33	$2,060	5	14	Modular
34	$10,310	8
35	$12,370	13
36	$3,095	5
37	$1,030	3
38	$0	3	13	$0			3
39	$620	3	12	$615			3
40	$2,060	8	14	Modular
VARIATION TO ACTIVE CONSTITUENT
41	$2,500	8	17	$1435			5
41A	Modular		18	$1,005			5
PERMITS
42	$620	3	20	$350			3
43	$0	N/A	22	$0			N/A
44	Modular		21	$350			Modular
45	$2,060	12	23	Modular
46	$1,030	6
47	$620	3
48	$0	N/A	19	$350			3
49	$620	3	21	$350			Modular
OTHER APPLICATIONS
50	$1,030	3	25	Modular
			24	Modular

Appendix B: Schedule 6 of the Agvet Code Regulations – Table of fees and assessment periods (Regulations 70, 76 & 78)

Item	Description of application	Period	Fee
Application for approval of active constituent contained in a chemical product, registration of the chemical product and approval of the product label
1.	Application for approval of an active constituent contained in a chemical product, registration of the associated chemical product and approval of the product label requiring a full assessment of the active constituent and chemical product.	15 months	$53,745
2.	Application for approval of an active constituent contained in a chemical product, registration of the associated chemical product and approval of the product label requiring less than full assessment of the active constituent and chemical product.	The modular assessment period	The modular assessment fee
Application for registration of a chemical product containing an approved active constituent and approval of the product label
3.	Application for registration of a chemical product containing an approved active constituent and approval of the product label if: there is no registered chemical product containing the active constituent; and a full assessment of the chemical product is required.	15 months	$34,925
4.	Application for registration of a chemical product containing an approved active constituent and approval of the product label if: there is a registered chemical product containing the active constituent; and the chemical product is to be used on a major food crop; and there are no relevant maximum residue limits; and poison schedule classification is required.	15 months	$23,330
5.	Application for registration of a chemical product containing an approved active constituent and approval of the product label if: the chemical product is similar to a registered chemical product; and chemistry and manufacture, efficacy and target species safety data are the only data required to demonstrate the similarity of the chemical product to the registered chemical product.	5 months	$3,630
6.	Application for registration of a chemical product containing an approved active constituent and approval of the product label if: the chemical product is closely similar to a registered chemical product; and efficacy and safety data are not required to demonstrate the similarity of the chemical product to the registered chemical product; and chemistry and manufacture data are required.	5 months	$2,470
7.	Application for registration of a chemical product containing an approved active constituent and approval of the product label if: the chemical product is closely similar to a registered chemical product; and efficacy and safety data are not required to demonstrate the similarity of the chemical product to the registered chemical product; and chemistry and manufacture data are not required.	3 months	$660
8.	Application for registration of a chemical product containing an approved active constituent and approval of the product label if: the chemical product is the same as a registered chemical product; and the chemical product is to be registered with a different name.	3 months	$595
9.	Application for a listed registration of a chemical product containing an approved active constituent and approval of a product label for which an established standard has been approved in accordance with section 56D of the Code.	3 months	$545
10.	Application for registration of a chemical product containing an approved active constituent (or an active for which the APVMA has received an application for approval) and approval of the product label for all situations other than as described in items 3 to 9.	The modular assessment period	The modular assessment fee
Application to vary a registration or label approval
11.	Application to vary particulars or conditions of registration or label approval where the variation is to extend the use of the chemical product to a new major food crop.	8 months	$15,685
12.	Application to vary particulars or conditions of registration or label approval if: the variation is to allow a minor change; and no data of a technical nature is required.	3 months	$615
13.	Application to vary particulars or conditions of registration or listed registration or label approval if: the variation is to allow a minor change; and no data of a technical nature is required; and the variation is a change required by the APVMA.	3 months	Nil fee
14.	Application to vary particulars or conditions of registration or listed registration or label approval if the application is not of a kind described in item 11 to 13.	The modular assessment period	The modular assessment fee
Application for approval of an active constituent
15.	Application for approval of an active constituent requiring a full assessment.	12 months	$25,775
16.	Application for approval of an active constituent requiring less than full assessment but requiring a toxicological assessment.	8 months	$4,430
17.	Application for approval of an active constituent requiring less than full assessment but not requiring a toxicological assessment.	5 months	$1,580
Application for variation to an approved active constituent
18.	Application to vary particulars or conditions of an approved active constituent.	5 months	$1,005
Application for a permit
19.	Application for a permit to possess or supply, other than for use in Australia, an active constituent that is not an approved active constituent or a chemical product that is not a registered chemical product.	3 months	$350
20.	Application for a permit where a previous assessment remains valid and no data of a technical nature is required.	3 months	$350
21.	Application for a permit where the proposed use is a minor use.	The modular assessment period	$350
22.	Application for a permit in respect of a chemical product or an active constituent if the proposed use of the chemical product or active constituent is determined by the APVMA to be an emergency use.	Not applicable	Nil fee
23.	Application for a permit in respect of a chemical product or an active constituent if the application is not of a kind described in items 19 to 21.	The modular assessment period	The modular assessment fee
Other applications
24.	Application made under section 10 of the Code (other than those of the kinds in items 1, 2, 3, 4, 5, 6, 7, 8, 10, 15, 16 or 17) requiring assessment of a technical nature.	The modular assessment period	The modular assessment fee
25.	Any other application: that is not made under section 10 of the Code; and that is not of a kind listed in an item of this Schedule requiring assessment of a technical nature.	The modular assessment period	The modular assessment fee

Appendix C: Module fees and timeframes

– amended from Schedule 7 to the Regulations to the Agvet Code

Module	Fee1	Timeframe2
1        Screening	$505
2.1     Chemistry	$3,255	12 months
2.2     Chemistry	$2,230	8 months
2.3     Chemistry	$1,030	5 months
2.4     Chemistry	$200	3 months
3.1     Toxicology	$19,490	12 months
3.2     Toxicology	$14,620	8 months
3.3     Toxicology	$2,900	4 months
4        Scheduling	$3,720	12 months
5.1     Residues	$5,595	12 months
5.2     Residues	$4,765	6 months
5.3     Residues	$2,490	6 months
5.4     Residues	$2,230	3 months
5.5     Residues	$1,175	3 months
6.1     OH&S	$4,310	12 months
6.2     OH&S	$2,900	6 months
6.3     OH&S	$1,435	4 months
7.1     Environment	$12,605	12 months
7.2     Environment	$3,255	6 months
7.3     Environment	$620	4 months
8.1     Efficacy & host animal safety	$1,865	5 months
8.2     Efficacy & host animal safety	$750	4 months
8.3     Efficacy & host animal safety	$500	3 months
9        Non-food trade	$1,175	5 months
10.1   Antibiotic resistance	Nil fee	12 months
10.2   Antibiotic resistance	Nil fee	6 months
10.3   GM Organism / other special data	Nil fee	6 months
11.1   Finalisation	$2,230	3 months
11.2   Finalisation	$1,175	2 months
11.3   Finalisation	$620	2 months
11.4   Finalisation	$160	2 months
12      Data protection	$170

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